Colesevelam for Children With Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

— WELKid DM  

Official title:

Colesevelam Oral Suspension as Monotherapy or Add-on to Metformin Therapy in Pediatric Subjects With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01258075
• Other study ID #: WEL-A-U307
• Status: Completed
• Phase: Phase 4
• Start date: February 24, 2011
• Est. completion date: April 21, 2020

Study information

• Verified date: April 2021
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy and safety of the study drug in treating type 2 diabetes in children 10 to 17 years old.

The groups will be low-dose (0.625 g Welchol) and high-dose (3.75 g Welchol). The children will have a 2 in 5 chance of being assigned to the low-dose group. They will have a 3 in 5 chance of being assigned to the high-dose group.

We believe the study drug will be safe, well tolerated, and improve blood sugar control in children 10 to 17 years old.

Description:

Colesevelam oral suspension will be studied as treatment of type 2 diabetes mellitus (T2DM) to evaluate clinical safety and efficacy in patients aged 10-17 years. The patients may have been treated with Metformin or have had no antidiabetic drug treatment in the previous three months.

Study Hypothesis: Colesevelam oral suspension for pediatric subjects with T2DM is safe, well tolerated, and shows improved blood sugar control (as evidenced by a significant change from baseline in hemoglobin A1C [HbA1c]).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: April 21, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

• Diagnosis of type 2 diabetes mellitus, as defined by the American Diabetes Association;

• Written informed consent of study participation

• Males and females aged 10 to 17 years, inclusive, at randomization (randomization must occur before 18th birthday);

• HbA1c at screening between 7.0% and 10.0%, inclusive;

• Fasting C-peptide >0.6 ng/mL; and

• Anti-diabetic treatment at screening:

• Treatment-naïve or untreated; OR

• On metformin monotherapy: Metformin monotherapy has been initiated prior to screening.

Exclusion Criteria:

• Fasting plasma glucose >270 mg/dL;

• Diagnosis of type 1 diabetes;

• History of more than one episode of ketoacidosis after the initial diagnosis of type 2 diabetes mellitus;

• Clinical laboratory assessments/evaluations, eg. autoimmune markers, aminotransferases, triglycerides, creatinine clearance, and Hb variants, that are not within the protocol-defined parameters

• Systolic blood pressure =150 mmHg or diastolic blood pressure =95 mmHg

• Use of medications not allowed by protocol-defined parameters, eg. insulin or any medication that affects insulin sensitivity or secretion, growth hormones/somatotropin, or anabolic steroids

• Genetic syndrome or disorder known to affect glucose

• Participation in a weight loss program or another interventional research study within 60 days;

• Female participants who are lactating, pregnant, or plan to become pregnant within 1 year of screening;

• Female participants who are sexually active and unwilling to use appropriate contraception for the duration of the study;

• History of bowel obstruction;

• Other significant organ system illness or condition (including psychiatric or developmental disorder) that, in the opinion of the Investigator, would prevent full participation

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• High-dose colesevelam
3.75 grams colesevelam hydrochloride in oral suspension
• Low-dose colesevelam
0.625 grams colesevelam hydrochloride in oral suspension

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 6	The percent change in HbA1c from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward.	Baseline to Month 6 post-dose
Secondary	Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12	The percent change in HbA1c from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward.	Baseline to Month 12 post-dose
Secondary	Change in Fasting Plasma Glucose (FPG) From Baseline to Month 12	Change from baseline was assessed for FPG values at Month 6 and Month 12 categorical time points.	Baseline to Month 12 post-dose
Secondary	Number of Participants Achieving a Response to Therapy to Month 12	Participants achieving a response to therapy, ie, glycemic control, were assessed with the last observation after 1 month before any rescue therapy carried forward at Month 6 and Month 12. Response to therapy was defined as HbA1c <7.0% or <6.5%, reduction in HbA1c =0.7% or =0.5% from baseline, and/or reduction in FPG =30 mg/dL from baseline.	Baseline to Month 12 post-dose
Secondary	Percent Change From Baseline to Month 6 in Plasma Lipids	The percent change in plasma lipids from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward.	Baseline to Month 6 post-dose
Secondary	Percent Change From Baseline to Month 6 in Triglycerides	The percent change in triglycerides from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward.	Baseline to Month 6 post-dose
Secondary	Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria	Rescue criteria was defined as HbA1c levels =8.5% after 3 months or =7.5% after 6 months (=173 days) (confirmed persistent hyperglycemia) of study medication treatment, as measured by the central laboratory.	Baseline to Month 12 post-dose

External Links

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